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FDA upgrades guide for 'breakthrough' status, other expedited programs

This article was originally published in Scrip

Executive Summary

Less than a year after releasing a guidance for four programs aimed at facilitating and expediting development and review of new drugs intended to address unmet medical needs for serious and life-threatening conditions, the FDA has finalized the document, upgrading its thinking on what biopharmaceutical makers need to do to meet the criteria for fast-track status, accelerated approval, priority review and the breakthrough therapy designation.



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